PREVENTING AND TREATING CHRONIC INFECTIONS SOFTOX SOLUTIONS AS - A NORWEGIAN MEDTECH COMPANY LISTED ON MERKUR, OSE
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Preventing and treating chronic infections
SoftOx Solutions AS
A Norwegian MedTech Company listed on Merkur, OSE
Disclaimer This Presentation has been produced by SoftOx Solutions AS (the “Company” or “SoftOx”), solely for use at the presentation to investors held in connection with the proposed private placement of shares by the Company. This presentation is strictly confidential and may not be reproduced or redistributed, in whole or in part, to any other person. To the best knowledge of the Company, the information contained in this Presentation is in all material respect in accordance with the facts as of the date hereof, and contains no material omissions likely to affect its import. However, no representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein, arising directly or indirectly from the use of this Presentation. This Presentation contains information obtained from third parties. Such information has been accurately reproduced and no facts have been omitted that would render the reproduced information to be inaccurate or misleading, as far as the Company is aware and able to ascertain from the information published by these third parties. Information in the following Presentation relating to the price at which relevant investments have been bought or sold in the past or the yield on such investments cannot be relied upon as a guide to the future performance of such investments. This Presentation does not constitute an offering of securities or otherwise constitute an invitation or inducement to any person to underwrite, subscribe for or otherwise acquire securities in the Company or any affiliated company thereof. This document contains certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. 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SHOULD ONE OR MORE OF THESE RISKS OR UNCERTAINTIES MATERIALIZE, OR SHOULD UNDERLYING ASSUMPTIONS PROVE INCORRECT, ACTUAL RESULTS MAY VARY MATERIALLY FROM THOSE DESCRIBED IN THIS PRESENTATION. THE COMPANY DOES NOT INTEND, AND DOES NOT ASSUME ANY OBLIGATION, TO UPDATE OR CORRECT THE INFORMATION INCLUDED IN THIS PRESENTATION. No representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein arising directly or indirectly from the use of this document. 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Neither the delivery of this Presentation nor any further discussions of the Company with any of the recipients shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since such date. 2
Risk factors
Investments in shares always entail a high degree of risk. Potential investors should give careful consideration to the specific factors listed below, which is a non-exhaustive list of
certain risks and uncertainties inherent in any investment in securities issued by SoftOx. Each of the risks listed below and other risks and uncertainties described could, if they are
realized, have a material negative effect on SoftOx's business, results of operations, financial position, or future operations, or result in a reduction in the value of SoftOx' shares.
The risks described below are not listed in order of significance and are not the only risks faced by the Group. Before making an investment decision with respect to the shares,
investors should, among other things, carefully consider the risk factors described herein and all information contained in this Presentation. An investment in the shares is suitable
only for investors who understand the risks associated with this type of investment and who can afford to lose all or part of their investment.
The materialization of any of the risk factors listed below or other risk factors could have a material adverse effect on the Company’s business, operating results or financial
condition
• SoftOx’s business is difficult to evaluate because the Company has a limited history and has generated limited sales revenue/profit since its incorporation. Its past performance does not necessarily
give a basis for its likely future results.
• SoftOx's success for the foreseeable future is highly dependent upon the commercialization of its product candidates. No assurance can be given as to whether or when these will be successfully
developed or commercialized or will generate revenues or whether the Company will be able to develop additional product candidates
• In the event the product candidates are commercialized, SoftOx is dependent on developing relationships with business partners, distributors and key customers or licensees, including attaining
sufficient market acceptance of its product candidates among physicians, patients, healthcare payers or the medical community.
• SoftOx's results of operations may be adversely affected by changes in the pricing environment and/or regulations for medical products
• SoftOx is dependent on its key personnel and employees and its ability to recruit skilled personnel for future operations
• Product development may not deliver expected results and may not be indicative of results in later stage trials, or may not result in the Company's pursuit of further clinical trials
• Any failure or delay in completing clinical trials for any of the Company's product candidates may prevent SoftOx from obtaining regulatory approval or commercializing product candidates on a
timely basis, or at all, which would require the Company to incur additional costs which may in turn delay receipt of any product revenue
• SoftOx may need to change the clinical programme to meet various health authorities' requirements, as well as to adapt to results from on-going clinical trials and other product improvement
metrics. Such change is likely to influence the overall capital requirement and revenue flow of the Company, including the costs and time required to complete the clinical programme
• SoftOx may become subject to burdensome government regulations affecting the industry, which could directly affect the Company's products and product development, which will in turn affect the
Company's overall capital requirement, revenue flows and time to commercialization.
• SoftOx may not obtain required marketing authorization from health authorities (domestic og multi-national (EU, etc.) for its products, which is required in order to enter the commercial phase.
3
Risk factors cont.
• SoftOx may face competition from new as well as from known competing products. If the Company is unable to compete effectively, in terms of its products or prices, it may have to alter the design
of its clinical programmes, its overall costs may increase and the Company may be unable to successfully commercialize its products or achieve the expected margins.
• The Company could become subject to liability claims in connection with clinical trials or otherwise in connection with the use or misuse of the Company's products after commercialization
• SoftOx expects to continue to incur substantial expenses related to further research and development of its product candidates, personnel costs, commercializing, support of patent rights, as well
as administrative functions. It is expected that the currently available funds will not be sufficient to meet the Company's needs or unexpected factors could arise that could increase the Company's
need for capital, and the Company expects that it will need to seek additional funding bay way of debt or equity capital. The Company may not be able to obtain the required funding or may not be
able to do so at acceptable cost. A future equity raising will dilute the ownership interest of existing shareholders.
• As of today, SoftOx has several projects that are partially funded by public grants. There is no assurance that SoftOx will continue to have grant applications approved in the future, on the same
terms or at all.
• SoftOx’s markets are undergoing rapid technological change, and the Company’s future success will depend on its ability to meet the changing needs of the industry
• SoftOx faces risks inherent to international expansion and operating in multiple jurisdictions
• SoftOx is dependent on its intellectual property rights and the Company’s methods of protecting its intellectual property rights may not be adequate
• SoftOx faces risks of claims for intellectual property rights infringement from third parties
• SoftOx depends in large part on its ability to protects its exiting patents and to obtain new patents, maintain trade secret protection, protect its trademarks and operate without infringing on the
proprietary rights of third parties. Third parties may have filed patent applications, or hold issues patents, relating to products or processes competitive with those that have been developed by the
Company, and this may impair the Company's ability to do business in a particular area. There can be no assurance that the Company's pending patent applications will be approved, either in a
timely manner or at all, that the Company will develop additional products that are patentable, that any patents issued by to the Company will provide the Company with competitive advantages or
will not be challenged by any third parties, that the patents or others will not prevent the commercialization of products incorporating the Company's methods, or that existing or former employees,
consultants or partners of the Company will not allege that they have rights to the Company's intellectual property. Furthermore, there can be no assurance that other companies will not
independently develop similar products, duplicate or reverse engineer any of the Company's products or, if patents are issued to the Company, design around the Company's patents. Filed patents
that are not granted may cause the development program can be terminated because of lack of market protection
• In the ordinary course of business, SoftOx is subject to credit risk in its contractual relationships with various parties
• SoftOx may not be able to earn the planned revenue or to raise sufficient working capital to fund its operations until its business generates positive cash flow
• SoftOx may face challenges in production of the products which may delay timelines, increase costs or stop the development of the product(s)
4
Highlights
SoftOx has discovered a unique combination of natural chemicals proven to
have superior antimicrobial effect compared to today’s solutions*
• First clinical trial in humans completed successfully
• Secured distribution agreements for hand disinfection (Kiiltoclean/Antibac) and
animal health (VESO)
• Cooperation with globally leading universities, and research teams
• Intends to raise NOK 40-75m in equity to finance studies and corporate development
Removing infections – critical for wound healing
*Company information; Filter grown Pseudomonas aeruginosa and Staphylococcus aureus embedded in biofilm
5
Company background
1 • Extensive experience from animal husbandry in the European agricultural sphere
• Key observations:
Background » 20% of cows suffer from chronic bacterial infections1
» Antibiotic treatments are mostly ineffective in biofilm infections and cause bacterial resistance
» Hypochlorous acid is also used, but is generally unstable and with limited effect
2 • Hypochlorous and acetic acid have long histories of use as antiseptics 2
• In collaboration with leading researchers in Lund, SoftOx started its research in 2008
Research
• The concept was further developed in 2016, supported by world leading professors at the Copenhagen University
• By combining hypochlorous acid with acetic acid, SoftOx has created a best-in-class non-toxic and clinically proven topical antiseptic
3
• Intellectual property is protected by a large and strong patent family; first patent granted in 2012
Patents • 20 patent filings; Important patents like composition method and product, NPWT acetic acid and sodium diacetate are granted,
others like the biofilm removal still pending.
1) https://albertamilk.com/ask-dairy-farmer/percentage-cows-suffer-mastitis/
6 2) Kramer A. Consensus on Wound Antisepsis. Skin Pharmacol Physiol 2018;31:28–58 Update 2018
Key personnel
Geir H. Almås, CPA – Chief Executive Officer & Founder Hans Jørgen Holum - CEO SoftOx Denmark & Head of Animal Health
• Extensive experience from business development • Over 20 years’ experience with international sales and management
positions
• Previously PwC and KLP Asset Management
• MSc in Business Administration from Copenhagen Business School
• MSc Business Administration (BI) and Chartered
Accountant (NHH)
Glenn Gundersen, PhD – Director Medical Affairs Advisory Board
• Over 25 years of experience from the pharmaceutical Thomas Bjarnsholt, PhD
industry, immunology/inflammation and oncology
• Professor of bacterial and fungal biofilms in chronic infections,
• Previously Bristol-Myers Squibb Norway, Biotec • Ranked as the world leading scientist on biofilms
Pharmacon, Biogen Norway, Roche
• Co-inventor of the technology with financial rights, see Patent and IP
• PhD Molecular and Cellular Biology (University of Oslo) • Works for the company as a consultant
• Member of the Global Wound Biofilm expert panel
Magnus M. Fazli, PhD – Head of Research
• More than ten years of experience in biofilm research Klaus Kirketerp-Møller, MD
• Since 2007, mainly focused on research on chronic wounds and bacterial biofilms
• Specializing in chronic wound biofilms, biofilm formation
and antibiotic tolerance • Co-inventor of the technology with financial rights, see Patent and IP
• Works for the company as a consultant
• PhD Medical Microbiology (University of Copenhagen),
and MSc Bio-entrepreneurship (Copenhagen Business • MD at Copenhagen University and specialist in orthopedic surgery, and chair of
School) Nordic Diabetic Foot Task Force
Hans Petter Grette – Sales and Marketing Director
Pål Rongved, PhD,
• 20 years marketing and executive management • Professor Pharmaceutical institute, University of Oslo
background from Lilleborg (Orkla)
• Member of The Norwegian Board of Appeals for Industrial Property Rights
• MSc Business Administration (BI) and AGSIM • Works as consultant for the company
International Management (Arizona, U.S.)
7
Key partners and contributors
Strong international support from key opinion leaders and institutions
8The challenge
Antimicrobial resistance
The ability of bacteria and other microorganisms to resist
the effects of an antibiotic/antiseptic to which they were
once sensitive
Biofilm resistance
Aggregated bacteria often covered by slime (biofilm matrix),
acting as a fortress and protect bacteria from attacks such as
antibiotic treatment and the immune system
SoftOx reinforces nature’s ability to fight antimicrobial resistance (AMR)
9A unique combination
Hypochlorous acid Acetic acid
• The body’s natural antimicrobial agent • Long history of use as an antiseptic
• Widely used but inherently unstable • Potentially effective deep within the wound bed
• Instantaneous microbial killing effect • Good stability
• Superior safety profile in efficient concentrations • Retains antimicrobial activity despite contact with organic
material (e.g. blood, tissue)
• Moderate antiseptic effect alone
• Widely used as food additive
• Well tolerated, e.g. drinking water
• Moderate antiseptic effect alone
The SoftOx Technology – the combination effect
• The combination works synergistically, and shows superior effect on microbes
• Does not induce resistance in bacteria. Effective in antibiotic-resistant bacteria (e.g. MRSA)
• Can be customized for specific purposes;
» Higher concentration of acetic acid increases the formula’s antimicrobial potency (biofilm eradication)
» Lower concentration of acetic acid yields a softer sting when applied to wounds (disinfectant, wound irrigation)
• Effectively stabilizes hypochlorous acid
10SoftOx works both on wound surface and beneath wound bed
The SoftOx Wound Model Success criteria for removal of infections
▪ Penetrate and kill microbes within the biofilm
Prevent infections
▪ Penetrate and eradicate biofilm also within the wound bed
▪ Not cause development of microbial resistance to the products
Penetrates wound ▪ Well tolerated
bed
Infection remover
Kills bacteria inside biofilm
Removal of infections → critical for wound healing
11Pre-clinical experiments show promising effects
In vitro in the lab Animal models
✓ A safe disinfectant with a unique ability to remove hard-to- ✓ No negative influence on wound healing
treat microbes embedded in biofilm
✓ Appears to be significantly more effective than competitors ✓ Well-tolerated in full-depth wounds
SoftOx against P. aeruginosa and S. aureus, the most common ✓ Significant bacterial reduction in wounds
bacteria in chronic wounds
✓ Did not induce resistance or cross-resistance development
towards antibiotics
Effectiveness on Pseudomonas aeruginosa1 Effectiveness on Staphylococcus aureus1
Effect
on
bacteria
in
biofilms
12 1) Company information
SoftOx SoftOxMultiple areas of use – current focus on hands and wounds
Humans Animals
Chronic otitis media, chronic Chronic and acute wounds; Mastitis
sinusitis, chronic tonsillitis, dental leg wounds in particular
plaque, pre and post operative
Peripheral vascular catheters,
stomi, urinary catheters and urinary
tract infections
Hand disinfection, eczema and
wounds
Orthopedic implants, prosthetic
joints and chronic wounds
SoftOx is effective against bacteria (also in biofilms), virus, fungus and spores
13Conducted preclinical and clinical studies
Cost
Study Objectives Results Completed
(NOK)
Costerton Biofilm Center: Multiple experiments Superior antimicrobial effect documented for a range of concentrations
on surface biofilms to define optimal (HOAc: 0.25%-4%, HOCl: 100-1000ppm). Tests showed significantly
Laboratory in vitro 2m 2018
concentrations of SOX. Comparison with better killing than all competitors. Pseudomonas aeruginosa seems
competitors. more sensitive than Staph aureus.
Dept Veterinary Clinical Sciences, Univ of
Animal (Horses) SOX exerted no harmful effects and was well tolerated. Wound score
Copenhagen: To test SOX in established
Wound healing, infected improvement. Significantly reduction of S.aureus (day 12 and 20). 0.6m Jul 2018
biofilm-infected horse legs to explore wound
wounds Proves that SOX works in infected wounds in vivo. (Proof of Concept)
scores/healing, antibacterial effects and safety.
CITOX Labs. GLP study to demonstrate
Animal (minipigs); wound All SOX-formulations were documented to be well tolerated, i.e. did not
tolerability and toxicity of SOX on wound 0.8m Aug 2018
healing impede wound healing.
healing.
All four SOX formulations confirmed to be well tolerated, limited irritation
Animal (minipigs); wound RTC (Italy): Preliminary test of 4 SOX for toxicity
in wound tissue. These results will be further exploited in the main study 0.4m Sep 2019
healing (higher doses than before to approach MTD).
(Q2-2020).
SWIS was confirmed to be safe and well tolerated. It also showed
Pilot study (first in human) to explore SWIS
antimicrobial effects and good wound healing results. User and patient
safety and performance in human patients with
Clinical study (SWIS-01) feedback was favorable. The pilot study will serve as an important 10m Sep 2019
Split Skin Graft Donor sites (acute wound
source for optimal design of next study (SWIS-02). (Proof of Concept in
model), n=12.
humans)
14 SOX: SoftOx test solutionsHuman pilot study on safety in 12 patients with acute wounds
Primary Objective
The primary objective of this clinical investigation is to document safety of the SoftOx Wound Irrigation Solution when used on split skin graft donor
sites1 in an adult population
Secondary Objectives
The secondary objectives are to document the SoftOx Wound Irrigation Solution capability to provide clean wounds for optimal reepithelization (including
microbiological control), and subject/user satisfaction when used on split skin graft donor sites in an adult population
Results: No serious adverse events | Well tolerated | Bacterial reduction confirmed | Excellent wound healing
Day 0 Day 21, 100% healed
Study confirms safety and bacterial reduction
15
1. Weingart D, Stoll P.(1993): Eur J Plast Surg 16:22-25Clinical studies in progress/to be conducted
Cost Expected to
Study Objectives
(NOK) be ready
Animal (minipigs); MAX RTC: Local tolerance, systemic effects and pathology in minipigs after repeated dosing (continuously for 28 days) with
4m Q2-3 2020
dose; wound healing increasing SOX-strengths. Aiming to achieve maximal tolerable dose.
Biocide (SafeDes) Skin Clinical testing of SafeDes hand disinfectant on healthy and experimentally induced eczema with respect to skin barrier
1.5m Q3-2020
Tolerability functions. Comparison with alcohol-based products.
Clinical Study Medical Pivotal, confirmatory, comparative trial in subjects with superficial (blister) and full depth (biopsy) wounds to demonstrate Late 2020 (if
10m
Device (SWIS-02) safety and performance, with focus on wound healing. n = est. 40 (tbd). start in Q2-20)
To test drug candidates in relevant patient population (infected chronic wounds), dose escalation, safety and efficacy
Phase I / II drug study 25m TBD, 2021
measures (i.e. proof of concept). n = test. 30 (tbd).
Phase III drug Confirmatory study in target population (chronic wounds). Preferentially together with a partner. >50m TBD
16 SOX: SoftOx test solutionsProduct development plan
1
Preclinical/EN Application market Market introduction Voluntary post
Hand Disinfection In vitro/EN studies
studies approval Nordic region market studies
SafeDes 1H2020 2020
2
Preclinical/EN Voluntary post
Animals In vitro/EN studies Pilot/PoC Market introduction
studies market studies
Infection prevention 1H2020 N/A
Infection treatment 1H2020 2H2020 2H2020
Preclinical/EN Market
Device & Drug Pilot/PoC Pivotal/phase 3
In vitro/EN studies studies introduction
3 SWIS 2020 2021/2022
4 Infection treatment 1H2020 2020/2021 To be decided To be decided
Completed studies
17Product portfolio
Biocide expected to be Medical Device
SoftOx platform
ready for Expected ready for Medical Drug
developed
market in 2020 market in 2021
1
Hand disinfectant
Ready for Nordic market 3
Wound Irrigation Solution
SoftOx
• Acute wounds
Technology
(Surgical/Burns/Cuts)
base
• Chronic wounds 4
Infection Remover
Chronic Wounds
“Biofilm Eradicator”
2
Animal health
Ready for Norwegian market
Product development plan based on the SoftOx platform
18Go-to-market strategy: 1 Hand disinfection
Sales channels and target market Healthcare savings and revenue scenario
USDm
▪ Sales through distribution partners
600
▪ Nordics/Baltics: Kiiltoclean (Antibac), market leader in the 576
region (est. >50% market share) 550
▪ Rest of Europe: In progress
500
▪ Premium product, aimed at healthcare workers
▪ 25-50%4 of healthcare workers (HCW) have skin problems on their 450
hands
400
▪ Does not cause dry skin with same antimicrobial effect as alcohol
▪ Planned to be made available in pharmacies, sold directly to large 350
clients and through consumer channels
300
Market size 250
257
200
18.8 million HCWs in the EU and the US 1,2
Whereof 13.3 million have irritated skin and eczema1
150
121
110
100
USD 1,0803 54
52
Value of effective prevention of hand eczema per HCW 50
17 23
5 4 11
1
0
2020 2021 2022 2023 2024 2025
USD 20.2 bn3 Savings Revenue
Value of hand health market in Europe and the US
Market share assumptions for each market entry: Y1 (1%), Y2 (2%), Y3 (3%), Y4 (5%), Y5 (7%)
1) ec.europa.eu/eurostat/Healthcare_personnel_statistics_-_nursing_and_caring_professionals 2015 & Presentation Prim. Univ.-prof Dr. Robert Strohal, Hospital Fledkirch
2) Center for Disease Control and Prevention (CDC) homepage https://www.cdc.gov/niosh/topics/healthcare/default.html
19 3) MedValue+, Radbound University Medical Center and Exite International’s Panel of 11 KOL/experts – “2019 Health Technology Assessment; SoftOx Hand-wash for Health Care Workers with Eczema”
4) World Health Organization – Guidelines on Hand Hygiene in Health CareGo-to-market strategy: 2 Animal wound- and disinfection market
Sales channels and market entry Animal care revenue scenario – gross market
USDm
▪ First distribution agreement with VESO, a strong distributor to
44 43
the Norwegian veterinary healthcare market
42
40
▪ Planned launch of first products in 2020 38
36
▪ Will seek strong strategic partnerships for entry in the rest of 34
32
Europe and the US
30
28
▪ Large potential for future line extensions 26
24
22
22
Market size 20
18
Dairy cows: 23 million (EU) & 9.5 million (US) 16
20-35%1 and 47-71%2
reported prevalence of clinical mastitis across 14
EU. Est. cost per case varies from USD 70-300 3. Est. cost in EU - 12 11
as high as USD 1.2-2 bn 10
8
Cats and dogs: 160 million (EU) & 185 million (US) 6 5
EU companion animal wound treatment market incl horses is est. at 4 3
USD 221 million with a CAGR of 6.5%4
2
0.2
0
Horses: 6,4 million (EU) & 9 million (US) 2020 2021 2022 2023 2024 2025
6-9 times higher spending on horse wound treatment than on cats
and dogs4
1) https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2009.1143r
20 2)
3)
https://ec.europa.eu/eip/agriculture/en/content/mastitis-control-organic-dairy
https://www.independent.ie/business/farming/dairy/mastitis-cases-can-cost-up-to-300-per-cow-35338174.html
4) FIOR – Europe animal wound care market report 2019-2026Go-to-market strategy: 3 Medical device (SWIS) 4 Infection remover (drug)
Market access and sales strategy Infection prevention market size2
▪ To secure market access Million acute wounds annually
▪ Clinical development plan Traumatic wounds
▪ Excite International 50.0
▪ KOL – University of Copenhagen Burns
~ USD 2 bn 5.0
▪ Reimbursement
Annual market size
▪ Regulatory
▪ Infection prevention medical device
▪ Infection remover – drug 250.0
▪ Partnering to secure total wound care solution and distribution Surgical wounds
External health economy assessment report Infection remover market size3
▪ Est. cost reduction by using SoftOx-technology on venous leg Million chronic wounds annually
ulcers (VLU) and diabetic foot ulcers (DFU) below1:
Venous leg ulcer
9.7
Treatment Prevention ~ USD 11 bn Other chronic wounds
VLU – USD 4,969 VLU – USD 643 Annual market size 16.2
DFU – USD 2,030 DFU – USD 2,692
10.0
Diabetic foot ulcers
4.5
Pressure ulcers
1) “MedValue health economic decision modelling; Decreased time to ulcer healing and prevention of clinical infections in diabetic foot and venous leg ulcers”
21 2)
3)
Wound Irrigation Solutions Market to 2027 - Global Analysis & Forecast by Product, End-user and Geography - ResearchAndMarkets.com
Wound prevalence and wound management, 2012-2020, Med Market Dilligence, 2013Existing products shall cover overheads and indirect costs
1 Hand hygiene - Antibac
▪ Distribution agreement with Kiiltoclean – the market leader in disinfection for healthcare industry
▪ Antibac-brand – strong brand recognition
▪ Premium non-alcoholic antimicrobial hand disinfection
▪ Provides access to pharmacies and whole stores
▪ Targeted sales channels: online stores, direct sales to large corporates and non-medical chain stores Revenue from sale of hand
disinfectant and wound-solution
➢ Expected market entry in 1H 2020. for animals is intended to
finance further clinical
2 development
Animal health - VESO
▪ Market leader on pharmaceutical products for animal and veterinarian industry in Norway
▪ Sale and distribution of SoftOx through VESO’s platform incl. veterinarians, webshop and pharmacies
▪ Intentional agreement for future JV on further product development for aqua culture and farming industry
➢ Expected market entry in 2H 2020.
3 Wounds - medical device & drug
Clinical trials are intended to be
▪ Clear plan to conduct further clinical trials to achieve classification as medical device and medical drug,
conducted to achieve status as
such as toxicity tests and RCT-studies
medical device and drug
➢ Expected market entry in 2021 (US) as a medical device.
22Intended use of proceeds – cash positive on operations
1 Enter the hand disinfectant market – NOK 10 mill
2 Enter the animal health market – NOK 8 mill
3 Increase production capacity – NOK 2 mill
Infection remover – NOK 25 mill
4 ▪ Conduct phase 1 and phase 2 trials (PoC) on infection remover wounds
(medical drug)
Finish clinical development SWIS – NOK 10 mill
5 • Conduct confirmative study (medical device)
General corporate purposes – NOK 20 mill
6 • including repayment of NOK 3 in debt to shareholders and transaction fees
23Key assumptions for market penetration – first two products*
Targets 2020 2021 2022 2023 2024 2025
Hand disinfection
No. of users 3,500 14,000 37,000 75,000 180,000 360,000
Target market share 0.5% 2% 1.3% 1.2% 2.1% 4.2%
Markets N, S, DK, IS N, S, DK, IS N, S, DK, G N, S, DK, G, N, S, DK, G, EU
UK, F UK, F, I, SP
Animal
Target market share 4% 0.6% 0.7% 3.1% 3.1% 6.2%
Markets N, DK Europe US, Europe US, Europe US, Europe US, Europe
24 *)First wound cleanser for humans expected to be ready for market in 2021 – Key assumptions for market penetration to be doneRevenue target scenario
Revenue scenario based on following key assumptions Preliminary sales projections
NOKm
• First two years’ budget income are independent of costs 1,400 1,367
1,300
• Profit sharing with pilot partners assumed initially, later 60/40 1,200
1,100
• Price estimated to be 10% of target costumers cost savings 1,000
900
• Market approval according to company’s aspirations 800
688
700
• For hand disinfection, we target the 25% with the most 600
500
severe hand eczema 400
313
300
• Revenue from acute and chronic wounds products not 200 156
100 72
included in this scenario 20
0
2020 2021 2022 2023 2024 2025
Revenue
Potential for solid gross- and EBITDA margins
25Investment proposition
$33B+ +80% Proven effect 2021
Large market Gross margin Successful clinical trial Ambition of cash
opportunity1 target2 in humans positive operations
Strong patent Leading distribution Collaboration with No antimicrobial
family protecting IP partners world leading scientists resistance
1) Calculated by adding the potential hand health, infection prevention and the infection remover market
26 2) Company estimateThank you for your attention!
Index and References
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